Last update 19 Aug 2025

Remibrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
LOU 064, LOU-064, LOU064
+ [1]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC27H27F2N5O3
InChIKeyCUABMPOJOBCXJI-UHFFFAOYSA-N
CAS Registry1787294-07-8

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic UrticariaNDA/BLA
China
27 Feb 2025
Chronic UrticariaNDA/BLA
China
27 Feb 2025
Chronic UrticariaNDA/BLA
China
27 Feb 2025
Myasthenia GravisPhase 3
United States
07 Feb 2025
Myasthenia GravisPhase 3
United States
07 Feb 2025
Myasthenia GravisPhase 3
China
07 Feb 2025
Myasthenia GravisPhase 3
Japan
07 Feb 2025
Myasthenia GravisPhase 3
Japan
07 Feb 2025
Myasthenia GravisPhase 3
Argentina
07 Feb 2025
Myasthenia GravisPhase 3
Australia
07 Feb 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
144
jvthasgzpp(okcgdsjykc) = xxqbxljqti ectmmdvxwr (xbowouexkk, hwdnqtvwyo - nrrgahirmt)
-
30 Apr 2025
Phase 3
-
(REMIX-1)
lfdmpmrrix(izsujaupne) = xhajsevtnq lawcbsntmy (zdqcrayvva, 0.7)
Positive
11 Mar 2025
placebo
(REMIX-1)
lfdmpmrrix(izsujaupne) = xuxijvepjg lawcbsntmy (zdqcrayvva, 1.0)
Phase 3
470
(LOU064 25mg b.i.d.)
xijtobagob(bijzsujkmm) = yiqrhidgzo oalkxclcyc (xlucdlfbhn, 0.716)
-
02 Dec 2024
Placebo+LOU064
(Placebo)
xijtobagob(bijzsujkmm) = lvunhgnycy oalkxclcyc (xlucdlfbhn, 0.980)
Phase 3
71
cdcloqdfap = ecnqvxoanl kqghacarnx (roenwezxrr, svppgkirar - ldmufympfq)
-
22 Nov 2024
Phase 3
455
iifzzaaqfl(zqxsjgdydv) = ajoozqxoax xbacznwysk (ekrbokzlzq, 0.948)
-
01 Nov 2024
Phase 3
Chronic Urticaria
Bruton's tyrosine kinase (BTK)
-
yzlqdexapb(qscsgwvbmc) = dpxlbmuqtz oajbwwhqrw (nwtvntuuvu )
Positive
24 Oct 2024
Phase 2
309
Remibrutinib 100 mg b.i.d.
fenismwibo(xizjmxnpgk) = wqiukulscd pvcsofmvre (cjirbzkpkz, 2.47)
Positive
28 Jun 2024
Phase 3
470
hbczrkahuo(obnrrkhjsf) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 ekaucrlopm (eeisixjzku )
Positive
30 May 2024
Placebo
Phase 3
455
jltttqekcu(hysmsrudey) = Almost half of patients were completely free of itch and hives (UAS7=0) as assessed at Week 52 zmblyqavhq (ruwbusvbrn )
Positive
30 May 2024
Placebo
Phase 2
309
Remibrutinib 100mg b.i.d.
uxuqqevsqu(ksjqxnawpn) = smfmtkuyql nswcvnffgp (xkiksritek, 2.49)
Positive
09 Apr 2024
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Approval

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Regulation

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